Kornimate/medical-research-clean huggingface dataset:
combined fluorocholine positron emission tomography and magnetic resonance imaging (fch-pet/mri) in curative treatment of a hepatocellular carcinoma

Conditions: Patients Eligible to a Curative Treatment for Primary HCC

Summary: hepatocellular carcinoma (hcc) is the fifth most common cancer in terms of incidence and the second in terms of mortality. at an early stage, which is based on a low number and size of liver nodules and the absence of extra-hepatic locations (milan criteria), a curative treatment can be performed, i.e. liver transplantation, surgical resection, or thermo-ablation. these treatments can lead to severe complications, so patients benefiting from them must be carefully selected. the correct identification of all hcc lesions at the time of the therapeutic decision is crucial. mri is the reference examination for diagnosis but its field of exploration is limited to the upper abdominal area and its sensitivity decreases for nodules of less than two centimetres. such lesions could actually be hcc that will cause early post-operative progression. positron emission tomography (pet; functional imaging) with fluorodeoxyglucose can provide prognostic information but impacts initial staging in less than 5% of cases. however, pet with fluorocholine (fch), available in france since 2010, could detect intra- and extra-hepatic hcc lesions not identified by conventional imaging, potentially impacting patient management (e.g. 52% of patients in a small case study). fch-pet/mri could therefore be the ideal examination for the initial staging of hcc, combining in a single multimodality investigation the reference morphological imaging technique and an efficient functional one. the hypothesis of this study is that fch-pet/mri is able to detect, in patients eligible for curative treatment, additional preoperative intra- and extra-hepatic early or metastatic hcc unseen or equivocal with conventional imaging (ct and mri) and responsible for recurrence or disease progression at 6 months.


Eligibility criteria:
inclusion criteria: * age ≥18 years old * primary hcc proven by histological or imaging examinations (lirad 4 or 5) * eligible for curative treatment (barcelona criteria) i.e. hepatic transplantation according to milan criteria, surgical resection, or thermo-ablation, according to a multidisciplinary decision care committee * affiliated to, or a beneficiary of, a social security system * written informed consent. exclusion criteria: * patient refusing curative treatment * patient with hcc not eligible for curative treatment according to conventional imaging (ct, mri) * patient with performance status \>1 * contraindication to mri * pregnant or lactating woman * adult ward of court (under guardianship or trusteeship)

Keywords: fch-pet/mri primary hcc curative treatment resection thermo-ablation transplantation
idp-023 as a single agent and in combination with antibody therapies in patients with advanced hematologic cancers

Conditions: NHL; Multiple Myeloma; Blood Cancer; Refractory Non-Hodgkin Lymphoma; Relapsed Non-Hodgkin Lymphoma; Refractory Multiple Myeloma; Relapsed Multiple Myeloma

Summary: this is an open label, phase 1/2, first-in-human, multiple ascending dose, and dose-expansion study of idp-023 administered as a single agent and in combination with or without interleukin-2 (il-2), and with or without isatuximab, daratumumab or rituximab to evaluate the safety, tolerability and preliminary antitumor activity in patients with advanced hematologic cancers.

idp-023 is an off-the-shelf, allogeneic cell product made of "natural killer" cells, also called nk cells. white blood cells are part of the immune system and nk cells are a type of white blood cell that are known to kill cancer cells. this is an open label, phase 1/2, first-in-human, multiple ascending dose, and dose-expansion study of idp-023 administered as a single agent and in combination with or without interleukin-2 (il-2), and with or without isatuximab, daratumumab or rituximab to evaluate the safety, tolerability, and preliminary antitumor activity in patients with relapsed and/or refractory advanced multiple myeloma (mm) or non-hodgkin's lymphoma (nhl), respectively. the study is divided into a phase 1 dose escalation phase and a phase 2 expansion phase. phase 1 (escalation phase): the primary objectives of phase 1 are to define the safety of different idp-023 containing regimens and to define the recommended regimen and phase 2 doses (rp2d) of idp-023. phase 2 (expansion phase): the objective of the phase 2 expansion cohort is to evaluate the safety and efficacy of idp-023 in advanced mm in combination with isatuximab or daratumumab and advanced nhl in combination with rituximab.

Eligibility criteria:
key inclusion criteria: * for mm patients: documented diagnosis of mm requiring systemic therapy and relapsed and/or refractory (r/r) disease after ≥ 3 prior lines of therapy. * for nhl patients: r/r disease and failed ≥ 2 lines of systemic chemotherapy. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * life expectancy of greater than 12 weeks per the investigator. key exclusion criteria: * impaired cardiac function or history of clinical significant cardiac disease. * human immunodeficiency virus (hiv) infection, active hepatitis b infection, or hepatitis c infection. * active sars-cov-2 infection. * has untreated central nervous system, epidural tumor metastasis, or brain metastasis.

Keywords: advanced hematologic cancers
microwave ablation for uterine fibroids

Conditions: Uterine Fibroid

Summary: this study is aimed to evaluate the clinical safety and effectiveness of microwave ablation (mwa) in treating patients with uterine fibroid.

percutaneous radiofrequency ablation (rfa) is another form of thermal ablation that has been used for the treatment of uterine fibroids. although rfa is more invasive when compared to high-intensity-focused-ultrasound (hifu), the treatment is less limited by the location of the lesions, and the treatment procedure is more time efficient. to further improve the technology of thermal ablation for uterine fibroid, percutaneous microwave ablation (mwa) could be a promising option because it allows increased efficiency of energy transmission and reduction in procedure time, and may allow effective treatment of large lesions.

Eligibility criteria:
inclusion criteria: 1. symptomatic fibroids with or without focal adenomyoma 2. female gender 3. age between 30 and 50 4. pre or peri menopausal with fsh less than 40 miu/ml 5. negative urine pregnancy test 6. uterine size less than 22 weeks based on physical exam assessment 7. dominant intramural fibroid greater than or equal to 3 cm and less than or equal to 10 cm on imaging. 8. good health other than history of leiomyomas. chronic medications may be acceptable at the discretion of the research team. 9. are using abstinence, mechanical (condoms, diaphragms) or sterilization methods of contraception and are willing to continue using them throughout the study. 10. willing and able to give informed consent. 11. willing and able to comply with study requirements. 12. normal menstrual cycle with endometrial pathology excluded exclusion criteria: 1. history of or current thromboembolic event (deep vein thrombosis, pulmonary embolus, stroke) 2. other pelvic pathology as indicated by history or mr imaging such as endometriosis, ovarian tumor, acute or chronic pelvic inflammatory disease 3. pregnant or positive pregnancy test 4. unexplained vaginal bleeding 5. untreated severe cervical dysplasia 6. abnormal adnexal /ovarian mass 7. intrauterine device 8. known recent rapid growth of fibroids, defined as a doubling in size in 6 months 9. known bleeding tendency 10. contraindication to mri due to severe claustrophobia or implanted metallic device.
efficacy of bifidus dr10 and oligo saccharides / micronutrient fortification of milk

Conditions: Diarrhea; Pneumonia; Febrile Illness; Growth; Child Development

Summary: the purpose of the study is to evaluate effect or fortifying milk with pre and probiotics or with micronutrients on prevention of diarrhea, pneumonia and other childhood illnesses and improvement in growth and development.

the 1993 world bank world development report (1) delivered a strong but sad reminder of the dramatic scale of suffering and death among preschool children attributable to pneumonia (2.7million in 1990) and diarrhea (another 2.5million deaths). in terms of "disability adjusted life years" (dalys) lost, in 0-4 years old children, respiratory infections account for 18.5% and 17.6% (in boys \& girls respectively) and diarrhea accounts of another 16.2% and 15.7% respectively. the development of effective interventions to reduce morbidity from these illnesses has become a humanitarian, economic and political imperative and essential in achieving the morbidity and mortality reduction goals that the "world summit for children" set a decade ago. therapy with oral rehydration solution (ors) for diarrhea, a cornerstone of the universal strategy for child survival, has low compliance due to having no effect on duration of diarrhea and has mixed impact on child mortality (2-5). present strategies for containing morbidity and mortality due to respiratory infection focuses primarily on antibiotic treatment. increasing prevalence of antibiotic resistant strains, poses a problem with the current strategy. lack of any truly effective and affordable preventive vaccine, for both diarrhea and pneumonia has aroused considerable interest in food based preventive interventions. in the recent years increasing recognition and evidence regarding the role of probiotics, and micronutrients like zinc, as both preventive and therapeutic agents against infections has made them a potential and promising candidate. this study is in fact two trial run concurrently with two milk preparation one fortified with pre and probiotics and second fortified with micronutrients and each having same milk unfortified as control.

Eligibility criteria:
inclusion criteria: * children aged 12-36 months at enrollment * resident of sangam vihar and likely to be in the area for 1 year. * parents consenting to participate in the trial. exclusion criteria: * children who have been given complete therapeutic/preventive course of iron in the last 6 months. * children currently as part of a different iron/zinc supplementation program. * children known to be allergic to milk. * children who are severely malnourished and requiring hospitalization.

Keywords: zinc iron probiotics prebiotics child health milk fortification randomized controlled trial
sensitivity of the insync sentry optivol feature for the prediction of heart failure

Conditions: Heart Failure, Congestive

Summary: the sense-hf study is a prospective, observational, international multi-center study prospectively evaluating the sensitivity and positive predictive value of the optivol fluid trends data in predicting heart failure related hospitalizations and health care utilizations associated with signs and/or symptoms of pulmonary congestion, and to define optivol clinical guidelines for subject therapy management.

the sense-hf study prospectively evaluates the optivol feature in the prediction of heart failure related events associated with signs and symptoms of pulmonary congestion and in the subject hf therapy management. the optivol feature is based on the measurement of daily intrathoracic impedance values, measurements that can be used to track changes in the subject's thoracic fluid status over time. an alert warns the patient whenever a programmable threshold has been reached. the study is divided into three phases. the first phase is double-blinded and designed to determine the sensitivity and positive predictive value of the optivol fluid trends data for the detection of heart failure related hospitalizations with signs and/or symptoms of pulmonary congestion. in the second phase of the study, the alert is turned on and the positive predictive value of the first optivol patient alert for the development of signs and/or symptoms of pulmonary congestion will be evaluated. the third phase of the study allows for remote subject therapy management using the optivol patient alert. the patient management strategy is then based on the experience gained in the second study phase physician actions taken in the occurrence of a patient alert will be summarized.

Eligibility criteria:
inclusion criteria: * successfully implanted insync sentry device (\< 34 days post implant or pocket revision)in the pectoral region; * at least one hf-related hospitalization that required administration of iv medication (inotropes, nitrates, diuretics) within the last 12 months * the subject has a market released, transvenous, high voltage right ventricular lead * the subject is able to detect a patient alert signal exclusion criteria: * \<18 years of age (or under a minimum age required by local law) * moderate to severe chronic obstructive pulmonary disease (copd) * post heart transplant or awaiting heart transplantation * primary pulmonary hypertension * renal insufficiency requiring dialysis amendment to the inclusion criteria (jul 06): * inclusion of patients with concerto/virtuoso devices. * at least one hf-related hospitalization that required administration of iv (or uptitration of the oral medication)(inotropes, nitrates, diuretics)within the last 12 months

Keywords: heart failure, congestive diagnostic ambulatory monitoring intrathoracic impedance
a study to assess choroideremia (chm) health outcomes

Conditions: Choroideremia

Summary: the primary objectives of this study are to describe disease progression and severity by age in participants with chm, to assess health-related quality-of-life, resource utilization and work productivity, and to assess quality-of-life, work productivity, and impact on daily activities in caregivers of participants with chm at different stages of disease progression.


Eligibility criteria:
key inclusion criteria: physician participants 1. at least 60% of time spent in direct participant care. 2. board-certified or eligible with a specialty in ophthalmology, such as retinal specialist, ird specialist, retinal surgeon. patient participants 1. chm diagnosis confirmed via genetic testing. 2. include any minimal disease severity requirement. 3. participant has at least one record of visual acuity measurement in the past 24 months, or has be assigned by the treating clinician as having severe va impairment of blind/legally blind by using one of the following methods: finger counting, hand movement, light perception / no light perception. key exclusion criteria: physician participants a. participating physicians must not be affiliated with an approved management organization. patient participants a. participants who received gene therapy or any other investigational treatment and participants who do not agree to informed consent. note: other protocol defined inclusion/exclusion criteria may apply.
mobile applications for exercise adherence and hand function in chronic stroke.

Conditions: Chronic Stroke Patients

Summary: stroke is a clinically defined syndrome characterized by an acute, focal neurological deficit due to vascular damage in the central nervous system. it is the second leading cause of death and disability globally. stroke is not a singular disease but results from a variety of risk factors, disease processes, and mechanisms. following a stroke, upper limb (ul) dysfunction affects 40-50% of individuals in the chronic phase, significantly impacting their ability to perform daily tasks. the latest trend in therapy involves the use of mobile video games within rehabilitation programs. these applications leverage the multi-touch interface of mobile devices to provide accurate monitoring of a patient's health status. many of these mobile games are specifically designed to offer therapeutic tools that enhance dexterity and improve adherence to exercise routines.

a randomized clinical trail (rct) design will be employed, conducted at johar pain relief center over 10 months following the synopsis approval. the anticipated sample size, accounting for a 20% attrition rate will be 32 participants in each of the study groups. group a will recieve mobile based video games along with task based therapy for exercise adherence and hand function while group b will recieve conventional physical therapy. the sampling technique will be non probability convenience sampling with inclusion criteria of including chronic stroke patients aged between 30 to 75 years, both male and female genders are included in the study. the data collection tools include national institute of health stroke scale (nihss) , fugl meyer assessment -ue (fm-ue) , game user experience satisfaction scale (guess) , exercise adherence rating scale (ears) and box and block test was applied. the analysis will be conducted using spss for windows software version 25. training session will last for 6 weeks which will be conducted 6 days a week. mobile based video games and task based training will focus on exercise adherence and hand function, mainly focusing on hand dexterity.

Eligibility criteria:
inclusion criteria: * male and female patients age 30 to 75 years were included. * chronic stroke patients ranging from 6 months to 2 years (41). * participants having a stroke severity score \> 6 on national institute of health stroke scale (nihss) (42). * modified ashworth scale score ≤ 3 of the affected upper extremity (44). * montreal cognitive assessment (moca) score ≥ 26 (45). * patients who are able to sit without support. * no contractures of the affected wrist and fingers. exclusion criteria: * participants who show the symptoms of global or receptive aphasia. * participants who have medical problems or co-morbidities that interdict their participation in the study (such as shoulder pain in the paretic limb). * patients with severe apraxia, somatosensory problems. * severe spasticity of the affected wrist and finger flexors.
efficacy and safety of daclatasvir plus asunaprevir in chronic hepatitis c

Conditions: Hepatitis C, Chronic

Summary: we perform this study to identity efficacy and safety of daclatasvir and asunaprevir in real practice.


Eligibility criteria:
inclusion criteria: 1. willing and able to provide written informed consent 2. males and females, ≥ 18 years of age 3. hcv genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, or intolerant or ineligible to p/r due to neutropenia, anemia, depression or thrombocytopenia with fibrosis/cirrhosis, or treatment naive 4. hcv rna ≥ 10,000 iu/ml 5. subjects with compensated cirrhosis are permitted 6. seronegative for human immunodeficiency virus (hiv) and hepatitis b surface antigen (hbsag) 7. negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug. additionally, all fertile males with partners of childbearing age and all females with childbearing potential must use reliable contraception method during the study and for 3 months after treatment completion. exclusion criteria: 1. inability or unwillingness to provide informed consent or abide by the requirements of the study 2. other than genotype 1 infection 3. prior treatment of hcv with hcv direct acting antiviral agents (daa) 4. patient who has any history of major organ transplantation with an existing functional graft or patient who has plan to receive organ transplant 5. diagnosed or suspected hepatocellular carcinoma or other malignancies 6. evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy 7. evidence of a medical condition contributing to chronic liver disease other than hcv 8. uncontrolled diabetes or hypertension 9. women with ongoing pregnancy or who are breast feeding 10. evidence of alcohol and/or drug abuse 11. patient who has ns5a resistance associated variant

Keywords: daclatasvir asunaprevir
hyperbaric oxygen therapy in acute ischemic stroke ischemic stroke recovery (pro00061930)

Conditions: Acute Ischemic Stroke

Summary: this study will critically examine the feasibility, safety and efficacy of hbot during inpatient rehabilitation (ipr) after acute ischemic stroke measured by non-disruption of 3 hours of daily therapy, frequency of neurological deterioration or complications (seizure, hemorrhage, brain edema), and functional communication, activities of daily living (adls) and mobility.

preclinical studies support that hbot augments several adaptive mechanisms following ischemic stroke, including neuroplasticity, cerebral angiogenesis, and regeneration of nerve fibers. the earlier the treatment, the greater potential for a therapeutic effect. however, logistical issues and safety concerns have prevented application of hbot in the hyperacute window, particularly when coupled with recanalization therapy as the risk of hemorrhagic conversion is highest, monitoring intervals are short, and the natural history is being altered by another treatment. by enrolling patients who are in the subacute phase of stroke who are admitted to an inpatient rehab facility, the risk of hbot is lower, monitoring intervals are longer, and the selected population has newly acquired and targetable stroke-related disability. further, the patients are in a supervised setting and available for daily one-hour treatments without disrupting their intensive multidisciplinary rehab plan thereby minimizing nonadherence to daily treatments. neuroimaging supports that injured, but not dead, brain cells can persist for months after an ischemic event. hypoxia mediates cellular activity and death through multiple mechanisms. ongoing decrease in oxygenation to the damaged area due to impaired blood flow works against cellular repair, recovery, and development of new synaptic connections. increasing oxygen availability has been considered as an obvious treatment for stroke. hbot has the potential to facilitate the recovery of injured or inactive neurons through increased blood flow and oxygen delivery.

Eligibility criteria:
inclusion criteria: * age 18 years and above * ischemic stroke proven on neuroimaging * within 7-30 days post-stroke on day 1 of treatment * admitted to touro inpatient rehab facility exclusion criteria: * pre-stroke modified rankin scale score \>2 * parenchymal hemorrhagic transformation (ph1 or ph2) * receptive aphasia such that recommendations for preventative measures to mitigate barotrauma cannot be followed * history of recurrent and unprovoked seizures requiring a change in management in the last 3 months to control seizures * pulmonary disease requiring supplemental oxygen or daily respiratory medication management (metered dose inhalers, nebulized treatment or steroids)